APPLICATION
ANDA040481
TYPE
ANDA
ORIGINAL APPROVAL
2003-08-21
LATEST ACTION
2020-07-16
ROUTE
INTRAMUSCULAR, INTRAVENOUS, PARENTERAL, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
DIGOXINPrescription
DIGOXIN 0.25MG/ML · INJECTABLE · INJECTION
Approval history
2020-07-16Labeling · Supplement 15 · standardAP
2020-07-16Labeling · Supplement 16 · standardAP
2016-11-02Labeling · Supplement 8 · standardAP
2016-11-02Labeling · Supplement 12 · standardAP
2012-04-27Labeling · Supplement 5 · standardAP
2010-05-18Labeling · Supplement 4AP
2003-08-21OriginalAP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
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